ivosidenib (tibsovo) Report issue

Small molecule Orphan Drug FDA Approved FDA Fast Track FDA Priority Review FDA
AACT Drugs@FDA PubChem

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NOW
  • Now
Ivosidenib (AG-120) is an inhibitor of isocitrate dehydrogenase 1 (IDH1) This experimental drug inhibits mutant IDH1, leading to increased differentiation and decreased proliferation in IDH1 positive tumors and thus is thought to be promising for the treatment of IDH1-mutated tumors. In vivo treatment with AG-120 of TF-1 cells, primary human AML patient samples expressing mutant IDH1 and primary human blast cells cultured ex vivo showed that AG-120 is effective at lowering 2-HG levels and restoring cellular differentiation. It showed promising results in a phase I trial in patients with relapsed or refractory acute myeloid leukemia and is being evaluated in Phase III in previously-treated subjects with nonresectable or metastatic cholangiocarcinoma with an IDH1 mutation.   NCATS

Chemistry

  • SMILES: FC1=CN=CC(=C1)N([C@H](C(=O)NC2CC(F)(F)C2)C3=CC=CC=C3Cl)C(=O)[C@@H]4CCC(=O)N4C5=NC=CC(=C5)C#N
  • InChIKey: WIJZXSAJMHAVGX-DHLKQENFSA-N
  • Mol. Mass: 582.961
  • ALogP: Missing data
  • ChEMBL Molecules: Missing data
More Chemistry

Pharmacology

  • Mechanism of Action:
  • Multi-specific: Missing data
  • Black Box: Missing data
  • Availability: Missing data
  • Delivery Methods: Missing data
  • Pro Drug: Missing data

Drug Pricing (per unit)

United States

$340.5607 - $441.9927
More Pricing Detail

Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

ag120 | ag-120 | ivosidenib

Organizations (24)

Research & Development (23)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (2)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (27)

Approved Indications (1)


 

Leukemia, Myeloid, Acute (approved 2018)

Experimental Indications - Clinical Trial Phases 1-4 (27)


 

Cholangiocarcinoma (Phase 3)

Chondrosarcoma (Phase 2)

Clonal Hematopoiesis (Phase 2)

Ependymoma (Phase 2)

Glioma (Phase 2)

Healthy Volunteers (Phase 1)

Hepatoblastoma (Phase 2)

Histiocytosis, Langerhans-Cell (Phase 2)

Leukemia, Myeloid (Phase 1)

Leukemia, Myeloid, Acute (Phase 3)

Liver Diseases (Phase 1)

Lymphoma, Non-Hodgkin (Phase 2)

Medulloblastoma (Phase 2)

Mutation (Phase 2)

Myelodysplastic Syndromes (Phase 3)

Myeloproliferative Disorders (Phase 2)

Neoplasm Metastasis (Phase 3)

Neoplasms (Phase 2)

Neoplasms, Germ Cell and Embryonal (Phase 2)

Neuroblastoma (Phase 2)

Neuroectodermal Tumors (Phase 2)

Osteosarcoma (Phase 2)

Rhabdoid Tumor (Phase 2)

Rhabdomyosarcoma (Phase 2)

Sarcoma (Phase 2)

Sarcoma, Ewing (Phase 2)

Wilms Tumor (Phase 2)

Overview

  • Highest Phase: Phase 3
  • # of Trials: 32
  • # of Trial Organizations: 23

Trials by Phase

Trial Phase Start Date Organizations Indications

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